Crinetics' PALSONIFY shows lasting efficacy in acromegaly treatment at ENDO 2026
Crinetics' PALSONIFY shows lasting efficacy in acromegaly treatment at ENDO 2026
Crinetics' PALSONIFY shows lasting efficacy in acromegaly treatment at ENDO 2026
Crinetics Pharmaceuticals has presented new long-term data on its acromegaly treatment PALSONIFY at ENDO 2026. The findings come from ongoing open-label extensions (OLEs) of its clinical programme. Researchers assessed the drug’s safety, efficacy, and impact on symptoms over extended use. In the PATHFNDR-2 study, IGF-1 levels dropped from baseline over time. At 48 weeks, the mean level was 1.06 times the upper limit of normal (ULN), and by 72 weeks, it fell to 0.96x ULN. MRI scans at 24 weeks also showed that seven of 83 patients had a pituitary tumour volume reduction of over 20%.
PATHFNDR-1 reported stable IGF-1 levels at both 48 and 96 weeks, with means of 0.82x ULN and 0.81x ULN. Across both OLEs, median scores on the Acromegaly Symptom Diary remained steady at all assessed timepoints.
An analysis revealed that IGF-I levels on PALSONIFY monotherapy matched parent study baselines. However, adding oral cabergoline further improved these levels. Combination therapy with PALSONIFY and cabergoline was well tolerated.
After two years, PALSONIFY proved effective and safe in patients switched from monthly injectable SRLs and in untreated individuals. Only four patients (2.4%) left the OLE due to adverse events. No new safety concerns emerged, with the most frequent issues being diarrhoea (15.6%), joint pain (11.4%), headache (11.4%), and urinary tract infections (10.2%). The data confirm PALSONIFY’s long-term stability in managing acromegaly symptoms and biochemical markers. The drug, taken orally once daily, maintained efficacy with a tolerable safety profile. These results support its potential as an alternative to injectable treatments.
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